Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
10/11 1999
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was carried out in compliance with Directive 92/69/EEC, B.4 "Acute Toxicity - Skin Irritation", 1992, and OECD Guideline for Testing of Chemicals No. 404 "Acute Dermal Irritation/Corrosion", 1992, with no deviations reported.
Cross-reference
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report Date:
2000

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
Swiss Federal Department of the Interior

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Actinol
- Physical state: solid
- Analytical purity: 99.5 %
- Lot/batch No.: 410016
- Expiration date of the lot/batch: 31 July 2000
- Stability under test conditions: stable under storage conditions, dissolved stable for 5 days at room temperature
- Storage condition of test material: room temperature, protected from sun light
- Other:

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Elevage Scientifique des Dombes, Chatillon sur Chalaronne, France
- Age at study initiation: males 13 weeks, females 14 weeks
- Weight at study initiation:
- Housing: individually in stainless steel cages equipped with feed hoppers, drinking water bowls, with wood and haysticks for gnawing
- Diet (e.g. ad libitum): pelleted Provimi Kliba 3418 (batch 65/99) ad libitum
- Water (e.g. ad libitum): community tap water Füllinsdorf ad libitum
- Acclimation period: one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 40-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: To:

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: clipped with electric clipper
Vehicle:
other: bi-distilled water
Controls:
no
Amount / concentration applied:
0.5 g of Actinol per animal was moistened with water prior to administration. The test substance was applied to a surgical gauze patch which was settled on approximately 6 cm2 of the intact skin of the clipped area. The gauze was covered with a semi-occlusive dressing, which was wrapped around the abdomen and fixed with tape.
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
one male, two females
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm2
- % coverage:
- Type of wrap if used: semi-occlusive


REMOVAL OF TEST SUBSTANCE
- Washing (if done): lukewarm tap water
- Time after start of exposure: 4 hours after start of exposure


SCORING SYSTEM:
The skin reaction was assessed according to the numerical scoring system listed in the EEC Commission Directive 92/69/EEC, 1992, at approximately 1, 24, 48 and 72 hours after the removal of the dressing, gauze patch, and test substance.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24-72 hours after removal of gauze
Score:
0
Max. score:
3
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
Application of the test substance to healthy, intact rabbit skin resulted in a primary irritation score of 0.00. Local signs (mean values from 24 to 72 hours) consisted of grade 0.00 erythema and grade 0.00 oedema. No signs of irritation were observed.
No staining by the test substance of the treated skin was observed. No irreversible alterations of the treated skin were observed nor were corrosive effects evident on the skin.
Other effects:
No clinical signs of systemic toxicity were observed in the animals during the test and observation period, and no mortality occurred. The bodyweight of all rabbits was considered to be within the normal range of variability.

Any other information on results incl. tables

no remarks

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based upon the referred classification criteria, Actinol is considered to be "not irritating" to the rabbit skin.
Executive summary:

The primary skin irritation potential of the test substance Actinol was investigated by topical application of 0.5 g to 6cm2 intact dorsal skin of each of three young adult New Zealand White rabbits according to Directive 92/69/EEC, B.4, 1992, and OECD Guideline No. 404, 1992. The duration of treatment was four hours. The scoring of skin reactions was performed 1, 24, 48 and 72 hours after removal of the dressing. The scores of each animal at the following reading times (24, 48, 72 hours) were used in calculating the respective mean values for each type of lesion.

The primary irritation score was calculated by totaling the individual cumulative scores at 24, 48 and 72 hours and then dividing by the number of data points. The primary irritation score was 0.00 (max. 8.0).

Local signs (mean values from 24 and 72 hours) consisted of grade 0.00 erythema and grade 0.00 oedema.

The test article caused no staining of the treated skin. No corrosive effects were noted on the skin of any animal at any measuring interval.

Based upon the referred classification criteria (EEC Directive 93/21/EEC, 1993), the test substance is considered to be "not irritating" to the rabbit skin.